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BRIEF-PCI: Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention

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ClinicalTrials.gov Identifier: NCT00111566
Recruitment Status : Completed
First Posted : May 24, 2005
Last Update Posted : November 28, 2013
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
Anthony Fung, MD, Cardiology Research UBC

Brief Summary:
This trial was designed to examine the efficacy of a brief versus a standard prolonged (18 hours) infusion of eptifibatide in preventing troponin I release following successful coronary stenting.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Myocardial Infarction Drug: eptifibatide Phase 4

Detailed Description:

Percutaneous coronary intervention (PCI) is a common treatment for patients with severe ischemic heart disease. In the majority of cases, the potent anti-platelet agent eptifibatide is administered (bolus followed by infusion for 18 hours). The principal reason to use eptifibatide for PCI is to prevent platelet aggregation and the associated ischemia and myocardial infarction (MI). With improved laminar flow following stenting, prolonged infusion of eptifibatide may no longer be necessary. We hypothesize that after successful stenting with good angiographic results, patients can have eptifibatide discontinued immediately without a higher risk of adverse ischemic outcome, i.e. death, MI or unplanned target vessel revascularization (TVR) by 30 days. MI is defined as creatine kinase-MB (CK-MB) concentrations elevated to more than three times the upper limit of normal or new pathologic Q wave as seen on electrocardiograms (ECG). In order to prove this hypothesis, we estimate a sample size of 2,100 patients.

Before embarking on a large-scale clinical trial, we propose a pilot study using serum troponin I elevation as a surrogate end-point. Troponin I is a sensitive biomarker of ischemic injury. The absence of troponin I release following PCI would suggest excellent short and intermediate term prognosis. For the pilot study, we seek to prove the hypothesis that following successful PCI with stenting, an abbreviated regimen of eptifibatide is not inferior to the standard infusion in preventing ischemic injury, defined as troponin I release if baseline value is normal, or as CK-MB more than 3 times upper limit of normal if baseline troponin I is elevated. For this pilot study, we estimate a sample size of 620 patients.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 624 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention
Study Start Date : December 2004
Actual Primary Completion Date : July 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 18 Hour infusion Drug: eptifibatide
Experimental: 4 hour infusion Drug: eptifibatide



Primary Outcome Measures :
  1. Ischemic injury is defined as troponin I release by 24 hours when the baseline troponin I is normal or by measuring creatine kinase (CK-MB) when the baseline troponin I is elevated. [ Time Frame: 24 Hours ]

Secondary Outcome Measures :
  1. 30-day all-cause mortality, non-fatal myocardial infarction (MI), and unplanned target vessel revascularization (TVR) [ Time Frame: 30 days ]
  2. Composite event rate of non-coronary artery bypass graft (CABG) major bleeding, all-cause mortality, non-fatal MI, and urgent TVR at 30 days post PCI. [ Time Frame: 30 days ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and non-pregnant female subjects
  • 18 years of age or older
  • Received aspirin, clopidogrel, heparin (unfractionated or low molecular weight [LMW]) and eptifibatide
  • Had a successful PCI procedure with at least one stent deployed
  • Availability of a hospital bed

Exclusion Criteria:

  • Use of alternative anti-thrombin therapy during PCI (e.g. bivalirudin)
  • High risk patients:
  • Acute ST elevation MI < 48 hours (either direct PCI or rescue PCI)
  • Unprotected left main PCI
  • Obvious large thrombus on angiography
  • Use of rotablation, atherectomy, or thrombectomy devices
  • Unsatisfactory PCI results:
  • Final thrombolysis in myocardial infarction (TIMI) flow < 3
  • High grade dissection (> type B, if not completely resolved at completion of PCI)
  • Evident or suspected thrombus
  • Distal embolization
  • Suboptimal stenting (> 20% residual stenosis)
  • Side branch closure (≥ 1.5 mm branch or with associated symptoms)
  • Abrupt closure during procedure (if prolonged > 15 min or not resolved at completion of PCI)
  • Clinical instability
  • Prolonged ischemia during PCI (> 15 min)
  • Increased hazard of eptifibatide infusion:
  • Unsatisfactory deployment of a closure device (if used)
  • Large peri-procedure hematoma making the continuation of eptifibatide hazardous
  • Any condition that will increase the hazard of continuing eptifibatide
  • Operator discretion
  • No informed consent
  • Active participation in other research studies (unless with special exemption)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111566


Locations
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1L8
Sponsors and Collaborators
Cardiology Research UBC
University of British Columbia
Investigators
Principal Investigator: Anthony Fung, MB,BS, FRCPC University of British Columbia

Publications of Results:
Responsible Party: Anthony Fung, MD, Principal Investigator, Cardiology Research UBC
ClinicalTrials.gov Identifier: NCT00111566     History of Changes
Other Study ID Numbers: C04-0359
First Posted: May 24, 2005    Key Record Dates
Last Update Posted: November 28, 2013
Last Verified: November 2013

Keywords provided by Anthony Fung, MD, Cardiology Research UBC:
Percutaneous Coronary Intervention (PCI)
Glycoprotein IIb/IIIa blockade
Ischemic complications following PCI

Additional relevant MeSH terms:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Eptifibatide
Platelet Aggregation Inhibitors